Essure

A 2015 review found the effectiveness of Essure is unclear due to the low quality of evidence. With perfect use another review found evidence of a 99.8% effective based on 5 years of follow-up. The reported insertional failure rates are "failure to place 2 inserts in the first procedure (5%), initial tubal patency (3.5%), expulsion (2.2%), perforation (1.8%), or other unsatisfactory device location (0.6%)". Upon follow-up, occlusion was observed to have occurred in 96.5% of patients at 3 months with the remainder occluded by 6 months. Follow-up For the Essure method, three months after insertion a radiologist is supposed to perform a fluoroscopic procedure called a hysterosalpingogram, to confirm that the fallopian tubes are completely blocked and that the woman can rely on the Essure inserts for birth control. A contrast agent (dye) is injected through the cervix, and an x-ray technologist takes photos of the Essure coils to ensure no contrast leaks past the Essure. ==Adverse effects==

Serious side effects may include persistent pain, perforation of the uterus and fallopian tubes, and migration of the coils into the pelvis or abdomen. Risks Procedural complications • Inability to place inserts (4%) • Cramping (30%) • Pain (13%) • Nausea/vomiting (11%) • Dizziness/light headed (9%) • Bleeding/spotting (7%) • Vasovagal response (fainting) (1.3%) • Perforation, expulsion, or other unsatisfactory location of the insert Long-term complications Sources: • Abdominal pain (3.8%) • Back pain (9%) • Menstrual cramps, severe (2.9%) • Pelvic or lower abdominal pain, severe (2.5%) • Gas/bloating (1.3%) • Headache (2.5%) • Heavier menstrual bleeding (1.9%) • Vaginal discharge or infection (1.5%) • Pregnancy (0.48%) and increased risk of ectopic pregnancy • Allergic reaction to the materials • Rash • Autoimmune disease (0.99%) • Weight changes • Depression • Hair loss • Suicide attempt (0.55%) ==Procedure==

A physician places the coils into the fallopian tubes by a catheter passed from the vagina through the cervix and uterus. Once in place, the ingrowth continues over a period of three months, resulting in blockage in the Fallopian tubes; the tissue barrier formed is supposed to prevent sperm from reaching an egg. During that intervening three-month period, women are advised to use an alternate contraceptive method. Unlike tubal ligation, it may not require a general anaesthetic (though is often done under general anaesthetic). Despite this, some women have reported considerable pain during the procedure. In one 2007 prospective study, the mean time for procedure was 6.8 minutes (range = 5–18 minutes) for a trained physician to perform. The procedure can be performed in a physician's office. The procedure is reported to be permanent and not reversible by the manufacturer. Nevertheless, several Essure reversals have been performed. Device The small, flexible inserts are made from polyester fibers, nickel-titanium, stainless steel and solder. The insert contains inner polyethylene terephthalate fibers to induce inflammation, causing a benign fibrotic ingrowth, ==Regulatory history==

A Facebook group called Essure Problems which had 33,140 members (as of 04/03/2017) called the method "E-hell" and mentioned mostly pain, bleeding, bloating and other side effects from the device. Some women had coils break and perforate their internal organs, or conceived and gave birth to a child, at a number well above what Bayer has been reporting. Since then Bayer provided two toll-free telephone numbers for patient complaints, In October 2013, the FDA stated that since the product was approved in 2002 it had received 943 reports of adverse events related to Essure, mainly for pain (606 of the complaints). In February 2016, the FDA issued a "black box" label to warn the public about the harmful complications associated with the use of this device and requested Bayer to conduct a new postmarket surveillance to follow 2,000 women for at least three years, comparing the effectiveness and safety of the device with other surgical contraceptive methods. Women and doctors were required to sign a decision checklist before Essure implantation, and to give consent to a test three months later to ensure the device was properly placed and functioning. In July 2020, Bayer published interim data from the FDA-mandated postmarket surveillance study comparing patients who received Essure to those who receiving a laparoscopic tubal ligation. The interim data reported the incidence of several side effects in each group. In Essure patients, chronic lower abdominal or pelvic pain occurred in 9% and abnormal bleeding in 16%, compared to 4.5% reporting pain and 10% with abnormal bleeding in the tubal ligation group. It also reported new allergic or hypersensitivity reactions in 22% of patients and no reports of new autoimmune disorders, although blinded independent verification was pending. Recruitment of patients receiving Essure into the postmarket surveillance study has ceased as the device is no longer available on the US market. ==Legal issues==

In August 2020, Bayer agreed to a US$1.6 billion settlement to resolve approximately 90% of the nearly 39,000 U.S. claims related to Essure. Bayer stated that the settlement did not imply any admission of wrongdoing or liability. In 2023, the device was the subject of a class action lawsuit in Australia. Over 1000 women joined the suit claiming that the device caused pain, suffering, and significant bleeding. The suit was dismissed in December 2024. == See also ==